Musculoskeletal News Roundup 7-July-17

July 7, 2017 | Blake Mossy

FUNDING

ConforMIS secured $15 million of the 2nd tranche of a term loan led by Oxford Finance. The new funding will be used as working capital. The debt financing is provide under a five-year, $50 million agreement, part of the company’s effort to support commercialization of its custom joint replacement implants.

EDGe Surgical secured $1.4 million in a Seed Round funding. The new capital will be used to support the launch of the company’s Ortho EDG, a single-use electronic depth gauge that assists surgeons in placing orthopedic screws.

REGULATORY

K2M received 510(k) clearance and CE Mark approval from the FDA for its NILE Proximal Fixation system, designed for complex spinal deformities. The system consists of bands and connectors for use with rod constructs. The CE Mark approval also includes the use of anchors, which are not cleared in the U.S.

Meditech Spine received 510(k) clearance from the FDA for its CURE Lumbar Plating (LP) System, a low profile titanium plate with a one-step locking mechanism, pre-lordosed for lumbar and sacral application and anterior and lateral procedures. The system will be combined with the company’s Talos-A Lumbar IBF device in a sterile and pre-packaged tray to reduce surgery processing time and implant related infection.

PRODUCT INTRODUCTION & UPDATE

Life Spine launched its portfolio of OSSEO-LOC implants, including its ProLift PLIF/TLIF and TiBOW Expandable TLIF spaces, for the treatment of spinal disorders. OSSEO-LOC is the company’s surface treatment technology that provides an osteophylic surface architecture for potential bone on-growth, which aims to negate potential challenges associated with surface treated implants.

SeaSpine launched its Mariner, a pedicle-based system for posterior spinal fixation. The system is designed to reduce the number of trays required for surgery and provide surgeons with multiple intra-operative options to facilitate posterior lumbar fixation. The device includes in-situ modularity, motion limiting heads, and rod versatility.

DISTRIBUTION

MedShape entered into a definitive agreement with ConMed for the acquisition of ExoShape Anterior Cruciate Ligament (ACL) fixation system, a manufactured from shape memory PEEK, the system offers a non-rotational deployment and interference fixation approach for ACL reconstruction. This transaction includes femoral and tibial soft tissue fasteners for fixation of soft tissue grafts in reconstruction procedures.

Ortho Development (ODEV) entered into an agreement with China Pioneer Pharma (CPP) for the distribution of ODEV’s Balanced Knee System (BKS) in China. The system is comprised of implants and instrumentation designed to address primary and revision total knee replacement procedures. BKS includes a patented locking mechanism specifically designed to minimize the micro-motion between the plastic tibial insert and the titanium tibial base plate implants.

CLINICAL

OrthoSpace announced the publication of positive data on the use of the InSpace subacromial spacer for the treatment of massive rotator cuff tears. The case series of 39 shoulders (37 patients) was published in Arthroscopy and demonstrated improved function and reduced pain in patients treated with the InSpace System. The InSpace System consists of a biodegradable balloon spacer deployed in the subacromial space between the acromion and the humeral head, allowing smooth gliding and frictionless movement between the two bones and emulating the function of the original bursa. It is usually placed arthroscopically in a procedure that requires only 10 minutes to perform.